VITALS

S2 Ep4 | Samir Patel, CEO, Moonlight Therapeutics, Homegrown Innovation: Microneedle Stamps for the Food Allergy Epidemic


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WELCOME TO VITALS, THE PULSE OF GEORGIA LIFE SCIENCES


In this incredible, timely, and informative episode of VITALS, Maria Thacker, the CEO of Georgia Life Sciences, interviews Dr. Samir Patel, President and CEO of Moonlight Therapeutics, who discusses the company's development of a micro-needle stamp for food allergy treatment. The technology, which aims to reduce side effects and improve patient adherence, is currently undergoing clinical trials. Moonlight has raised $9 million in SBIR funds and secured additional support from the NIH and the DoD. Patel emphasized the importance of simplifying product design and understanding regulatory requirements. He also highlighted the need for better ecosystem support in Georgia, advocating for more active networking and marketing of local innovations.

Introduction and Background of Dr. Samir Patel
  • Maria Thacker introduces the podcast and welcomes Dr. Samir Patel, President and CEO of Moonlight Therapeutics.
  • Dr. Patel shares his background as an engineer turned entrepreneur, co-founding ClearSide Biomedical.
  • He discusses his educational background, including his PhD from Georgia Tech and dual Bachelor's degrees from UC Berkeley.
  • Dr. Patel explains his initial interest in the tech world and his pivot to the life sciences after a co-op at a J&J company.
Moonlight Therapeutics and Food Allergy Focus
  • Dr. Patel talks about his move to Georgia and his interest in food allergies, which led him to start Moonlight Therapeutics.
  • He describes the initial challenges and the unmet need in the food allergy space.
  • Dr. Patel shares how he connected with a Georgia Tech professor to start researching food allergies.
  • The company officially formed in 2019, focusing on a micro-needle stamp approach to food allergy care.
Technology and Clinical Trials
  • Dr. Patel explains the microneedle stamp technology and its benefits over existing food allergy treatments.
  • He discusses the current approved therapy for food allergies and its limitations.
  • The microneedle stamp aims to deliver allergens through the skin, avoiding GI side effects and making the treatment more convenient.
  • Dr. Patel highlights the importance of user experience and simplicity in product design.
Regulatory Challenges and Investor Landscape
  • Dr. Patel shares insights on the regulatory process and the importance of understanding FDA requirements.
  • He discusses the challenges of being a combination product and the impact on investor interest.
  • Dr. Patel explains how the regulatory landscape has influenced his approach to product development.
  • He emphasizes the need for efficient use of capital and resources in the regulatory process.
Clinical Trial and Future Plans
  • Dr. Patel talks about the upcoming clinical trial for Moonlight Therapeutics, focusing on safety and efficacy.
  • He explains the importance of finding a safe dose and monitoring immune markers in patients.
  • The trial will be conducted in Georgia, with sites in South Carolina and other Southeastern states.
  • Dr. Patel shares the company's long-term goals, including expanding the treatment to other allergens and developing combination therapies.
Advice for First-Time Founders
  • Dr. Patel provides advice for first-time founders, emphasizing the importance of intellectual property and market understanding.
  • He discusses the need for a clear regulatory pathway and the role of non-dilutive funding in early-stage development.
  • Dr. Patel highlights the importance of networking and advocating for the company within the ecosystem.
  • He shares his experience with government grants and the value of leveraging multiple funding sources.
Impact of Non-Dilutive Funding
  • Dr. Patel explains how non-dilutive funding, such as SBIR grants, can support early-stage companies.
  • He discusses the challenges of balancing research and product development to attract investors.
  • Dr. Patel emphasizes the importance of using government grants to move the product through the development process.
  • He shares his experience with the DoD grant and the need for creative funding strategies.
Georgia Ecosystem and Future Goals
  • Dr. Patel discusses the strengths and gaps in the Georgia life sciences ecosystem.
  • He emphasizes the need for better marketing and advocacy for Georgia's research and innovation.
  • Dr. Patel highlights the importance of networking and engaging with larger ecosystems to attract investment and support.
  • He shares his vision for the future of Moonlight Therapeutics and the broader impact on food allergy treatment.
Personal Insights and Final Thoughts
  • Dr. Patel shares a personal anecdote about gardening and its connection to starting companies.
  • He explains the parallels between growing plants and developing successful products.
  • Dr. Patel expresses his gratitude for the support and opportunities in Georgia.
  • Maria Thacker concludes the podcast, thanking Dr. Patel and the listeners, and highlighting the importance of community engagement and advocacy.


About Georgia Life Sciences

As the leading advocate for the state’s dynamic and diverse life sciences sector, Georgia Life Sciences’ mission is to advance the growth of Georgia’s life sciences industry through partnerships and initiatives that accelerate innovation, investment, and job creation. To accomplish this mission, Georgia Life Sciences conducts economic development activities; advocates on behalf its members on public policy matters; educates the public about the benefits of life sciences research and product development; and provides a network for idea exchange and cooperation.

For more information on the impactful work, to join as a member, or provide support to the mission, please visit Georgia Life Sciences at https://www.galifesciences.org/

About Cloudcast Media

As the national leader in local podcasting to create a "listen where you live" mindset, Cloudcast Atlanta, a division of Cloudcast Media, proudly produces "VITALS: The Pulse of Georgia Life Sciences" through its CauseCast platform to help amplify, augment, and accelerate the mission and reach of community social impact organizations.  For more information on Cloudcast Media, please visit their website at CloudCast Media.

This episode was produced by Senior Associate Producer Brandon Joe. The episode was recorded, engineered, mixed and mastered by Sky Guides Atlanta, the podcast program and studio affiliated with the Russell Innovation Center for Entrepreneurs (RICE) in Atlanta, Georgia.
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